Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

This study has been completed.
Sponsor:
Information provided by:
Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier:
NCT00917137
First received: June 9, 2009
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.


Condition Intervention
Pulmonary Nodule
Pulmonary Mass
Procedure: TBNA + transbronchial lung biopsy + bronchial washing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate

Resource links provided by NLM:


Further study details as provided by Maggiore Bellaria Hospital, Bologna:

Primary Outcome Measures:
  • Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the predictor variables associated with a positive TBNA result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Compare the performance characteristics of TBNA and transbronchial lung biopsy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peripheral pulmonary lesions Procedure: TBNA + transbronchial lung biopsy + bronchial washing

Detailed Description:

In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients with pulmonary nodule or mass referred for bronchoscopy to the Thoracic Endoscopy Unit of Maggiore Hospital (Bologna Italy)

Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Pulmonary nodule (< 3 cm) or mass (> 3 cm) at computed tomography

Exclusion Criteria:

  • Refusal to sign informed consent
  • Uncontrolled coagulopathy
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00917137

Locations
Italy
Maggiore Hospital
Bologna, Italy, 40133
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
  More Information

No publications provided

Responsible Party: Marco Patelli, Maggiore Bellaria Hospital
ClinicalTrials.gov Identifier: NCT00917137     History of Changes
Other Study ID Numbers: 02-Trisolini
Study First Received: June 9, 2009
Last Updated: June 22, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Maggiore Bellaria Hospital, Bologna:
Lung cancer
Lung nodule
Transbronchial needle aspiration
Transbronchial lung biopsy
Bronchoscopy

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014